MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-04 for SODASORB LF * manufactured by Wr Grace.
[1279240]
Nursing assistant was preparing to change co2 absorbent on anesthesia machine and observed that unopened container of absorbent had changed color, hence not useable. Examination revealed that there was a perforation in the outer plastic film wrap covering the container. Two previous reports on different lot numbers of this item have been filed. Manufacturer response (as per reporter) for co2 absorbent, sodasorb lfleft message for manufacturer's representative and expect a call back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1570070 |
| MDR Report Key | 1570070 |
| Date Received | 2009-12-04 |
| Date of Report | 2009-12-04 |
| Date of Event | 2009-12-03 |
| Report Date | 2009-12-04 |
| Date Reported to FDA | 2009-12-04 |
| Date Added to Maude | 2010-01-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SODASORB LF |
| Generic Name | CO2 ABSORBENT |
| Product Code | BSF |
| Date Received | 2009-12-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | CX01-P128-08 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WR GRACE |
| Manufacturer Address | 2051 WAUKEGAN ROAD DEERFIELD IL 60015 US 60015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-04 |